Martin has sent this excellent reply. My response to him is appended below it. I have placed this in it's own thread as I think it deserves it!
Dear Greg,
Thank you for your interest. Our Chief Medical Officer, Dr Neil Frazer, is an anaesthetist and practiced for 7 years in Scotland before moving to the US and spending 25 years on FDA approvals with Glaxo mostly in oncology, Dr Frazer has done 10 FDA approvals with a 100% success rate. Ones� expertise is always open for new experiences and it is the adaptability that is important as much as the training.
Your concerns are misplaced.
Firstly, each country is their own legal jurisdiction. You must respect this and also as a company we must make sure that we obey the laws and provide the best value both for patients and for shareholders. Dubai/United Arab Emirates views CVac as a blood product and we must follow those laws for patients and physicians/oncologists which we have demonstrated to do.
The main thing in medicine is a simple practice. �Do no harm� or balance benefit to downside. CVac is mostly composed on the patient�s own white blood cells before they do chemotherapy, does no patient harm for cancer patients and one of the main reasons we as a company feel comfortable in providing CVac.
One of the oncologists we will work with used to be a principle investigator at Mt Sinai hospital(New York USA) and a Professor at John Hopkins university and actively enrolled patients in the Dendreon Provenge prostate cancer vaccine study and now today for the last year works in Dubai and he sends patients from the United Arab Emirates to the US for treatment of Provenge which today they pay for the use. This doctor already knew about CVac from our clinical data and is interested in prescribing it for renal cancer patients. We hope to provide such an opportunity whereby the oncologists sees there is benefit for their patient.
The US is different to the Europe and often drugs are approved in Europe but are not approved in US and vice a versa, the same goes for Australia or almost any other country. You must also remember that regulatory approvals are not the be and endall of if a drug works or is appropriate, it is only a guide of science that each legal jurisdiction makes on its best judgement.
For instance our Chief Operations Officer Matt Lehman used to be in charge of and work on drug approvals running a CRO with 120 staff. One of the drugs they worked on Removab which is for Malignant Ascites in ovarian cancer. It was approved after the phase II study in Europe in 2009 but they had to wait to the end of the phase III study to get approval in US which hasn�t happened as yet. This is completely ethical.
Also in Australia we expect to get approval for CVac before the US and EU phase III study is complete. This is because in Australia CVac is categorised as a category 3 blood product, very much like the UAE. You must show that the product is safe and has some efficacy which we have shown in 13 years of clinical data(human trials) in Australia and recently in the US. Our early studies were on mucin-1 positive cancer patients not just ovarian cancer and we have plenty of data on this. Currently we provide the treatment in Australia for patients outside of the ovarian cancer trial under the Special Access Scheme. These are completely ethical and we make sure that their full medical supervision, oversight from two qualified doctors and take each case under special consideration. We take patient health and safety seriously.
Our phase III study CVac ovarian cancer study is about statistical significance in providing a submission for the US FDA and European EMA. We have sought a large number of patients and look for biostatistics on a particularly label and indication. This study costs $40-$50m and takes 3 years so we must be judicious with our resources before we look at every single application and indication in a label expansion, ie. We are best to get it approved on one indication in the US and EU first then expand the label. In the meantime if there are other countries that want to see the application and make this available for their citizens then we will make sure that we can comply with those laws and also respect our other stakeholders in generating the value.
I don�t spend too much time on chat forums but if you wish to pass this information on please do so.
Thank you for your support and feel free to call me and I can arrange for you to speak to one of the doctors or scientists in our team that can discuss this further with you.
Thank you so much for your prompt and thorough reply. I am feeling much better about your strategy as it is clear you are not trying to bypass established trial processes but are providing a treatment with well established safety data to populations who are seeking it with open disclosure. Clearly there is substantial rigour required for entry into the US market, but I accept that that is not necessarily the be all and the end all. The safety data is crucial to any deployment of this treatment. Your reassurance on this matter in particular is very important.
Kind regards Greg
PRR Price at posting:
26.7¢ Sentiment: Buy Disclosure: Held
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